| PHUSE collaborations are organised into a number of specialist Working Groups, each with a broad topic area. The Working Groups have specific projects designed to achieve a set of particular objectives. |
| This page will highlight the latest news and information from our projects. Participation is open to anyone who wants to contribute and if you would like to get involved, please |
| email workinggroups@phuse.global. |
Data Transparency Summer Event 2022
Data Transparency Summer Event: Last chance to register! Taking place 28-30 June, this virtual and free event is not one to be missed. Click here to view the full agenda and to register.
CSS 2022
CSS: This year's PHUSE/ FDA CSS takes place 19-21 September. To find out more, take a look at the agenda on the PHUSE website. For this event, the reduced Early Bird rate ends 1 July. Don't miss out, Click here to register!
| Open Source – Regulatory Acceptance of Open-Source Submissions |
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Registration for the Open Source Open Forum is open! The Open Source Technology in Clinical Data Analysis (OSTCDA) project is hosting their fourth Open Forum: Regulatory Acceptance of Open-Source Submissions, they will be addressing the following questions:
Come and be a part of our next virtual Open Forum on 12 July at |
The Role of the Statistician and Statistical Programmer in Real-World Data Analysis:
The Real World Evidence project, part of the Emerging Trends and Technologies Working Group, presents the next PHUSE Community Forum, taking place 6 July,15:00(BST) |
10:00( |
EDT). |
Use of real-world data in regulatory submissions is growing. Real-world data provides unique insights which can be used for informed decision-making, resulting in faster drug approval. However, the nature of real-world data is quite different from that of clinical trial data. While the latter can be controlled at all stages, from collecting to reporting, this is not the case for real-world data. This imposes many challenges including pre-study alignment with regulatory agencies regarding validity of the data used. How does this affect the roles and corresponding responsibilities of various cross-functional clinical team members?
This meeting will start with a 30-minute presentation focused on the changes necessary
to use real-world data followed by a forum discussion on how this affects
the role of the statistical programmer and the statistician.
Date: 6 July 2022
Time: 15:00 (BST)/ 10:00 (EST)
Recently Published Deliverables
Bio-research Monitoring Data Reviewers Guide (BDRG) – The Optimizing the Use of Data Standards Working Group and the PHUSE BIMO Project Team are pleased to announce the publication of the Bio-research Monitoring Data Reviewer’s Guide (BDRG) Package. This reviewer’s guide was created to provide the industry with a consistent way and usable format for communicating information concerning the Bio-research Monitoring (BIMO) data to regulatory agency reviewers. The BDRG package includes an Introduction and Overview, Template, Completion Guidelines and three Examples.
Recommendations for SEND Dataset QC Best Practices – The SEND Dataset QC Best Practices project within the Nonclinical Topics Working Group have been busy working on a new deliverable which has recently been published. The White Paper provides key insights into current QC activities performed by industry as well as best practice recommendations for QC procedures. The aim is to promote more consistent QC procedures to help regulatory reviewers be more confident the SEND data accurately represents the data in the study report.
SDTM ADaM Implementation FAQ- The SDTM ADaM Implementation FAQ project, under the Optimizing the Use of Data Standards Working Group, has published a new response to a question they received under Validation/Conformance Rules. The question is based on whether an SDTM domain that is in the SDTM IG v3.3 be used for a study that is using the SDTM IG v3.2 to map the study data.
For more information on the PHUSE Working Groups and their projects, click here. If you would like to become a valued member of PHUSE and volunteer for one or multiple projects, please email: workinggroups@phuse.global.
The Dataset-JSON as Alternative Transport Format for Regulatory Submissions project within the Optimizing the Use of Data Standards Working Group, has published a new white paper. A pilot was executed to test the feasibility of using Dataset-JSON as a transport format for study data submitted with regulatory applications. The goal was to demonstrate that Dataset-JSON can serve as a transport file for study data without loss of data and no significant impact to business operations. CDISC Dataset-JSON is a modern dataset format designed for data exchange. Many software applications already import and export JSON and in the longer term more significant benefits will emerge as the constraints imposed by XPT are removed. Overall, the findings were consistent across industry and the FDA supporting the use of Dataset-JSON as an alternative transport format for XPT v5. There were several key findings from the pilot and the solutions to these will be implemented in Dataset-JSON v1.1 (due end of 2024). PHUSE and CDISC will continue to collaborate with the FDA/PMDA to discuss next steps for regulatory support. FDA/CDER/CBER testing strongly suggests that analytical tools used for regulatory review are updated to take advantage of the metadata and flexibility provided by the Dataset-JSON format. The SEND Industry Feedback Surveyproject within the Nonclinical Topics Working Group, has published the 2024 SEND Survey Results. The survey was presented at the PHUSE/FDA Computational Science Symposium (CSS) 2024 and covered topics such as Manual Edits, Implementing SEND, Harmonisation and Next Steps. The Adverse Event Collection Recommendations project within the Safety Analytics Working Group, has published a new white paper The Adverse Event Collection Recommendations. This white paper provides recommendations for adverse event (AE) collection and associated instructions for Phase II to III clinical trials, building on standardisation efforts by Clinical Data Interchange Standards Consortium (CDISC) and PHUSE. The primary intent is to reduce the variation in AE collection and instructions to improve the site experience and the quality of the data. The Quality and Reusability of Real World Data project within the Real World Evidence Working Group, has published two new Blogs! The 'Understanding the Data Quality Issues in Real-World Data Through Real-World Examples', blog takes a closer look at the experiences shared within the dedicated Working Group in exploring the types of data quality hurdles encountered when using Real-World Data (RWD).The 'Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products' blog explores the use of Real-World Evidence (RWE) as a powerful tool for informing regulatory decisions and advancing medical innovation. The Educate the General Population on Data Privacy and Data Sharing project, within the Data Transparency Working Group has published video 2 of their series. The 'What Will I Receive and When Will I Receive It?’ The video covers topics such as the concept of consent to participate in a clinical trial, an overview of trial design and treatment procedures to develop a strong foundational understanding of clinical trials. To view the full series of videos created by this team, visit the PHUSE website. |
The Enhanced Risk-based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials, a new project within the Risk Based Quality ManagementWorking Group, is now calling for volunteers. This project aims to to discuss and focus on a robust strategy/process and best practices for:
If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 5 July Multiple projects within Working Groups are open to join. PHUSE welcomes new members who can apply their knowledge to bring fresh ideas and contribute to the ongoing work of PHUSE projects. For more information, click here, read the Welcome Pack or email workinggroups@phuse.global. |
Working Groups Report: Includes project updates, recent and upcoming deliverables and future plans for each Working Group. | |
Monthly Mailings: The monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE. | |
PHUSE Blogs: Fancy a quick read? A blog is a perfect way to catch up on all things Working Groups. Get the lowdown on the latest events from across the globe and stay updated on industry topics brought to you by industry professionals. |
Initiate and lead a new project under the PHUSE Working Groups umbrella. The new project must address problems of significant relevance to computational science related to drug, |
biological and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements:
New projects can be submitted anytime during the year, click here to submit |
Working Groups Latest Report: Q12022
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PHUSE Blogs
PHUSE Diversity & Inclusion Survey
Neurodiversity: Join the ConversationCan Clinical Data processed with R be Used in a Regulatory Submission?
Pharma Statistical Programming Heads Council
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